FLEET BAGENEMA

Additional Manufacturer Narrative

CONSUMER HAD THROWN THE ENEMA BAG AWAY BUT STILL HAD THE BOX. INVESTIGATION SUMMARY AND CONCLUSION: THERE WERE NO QUALITY INCIDENTS, DEVIATIONS OR ADD'L COMPLAINTS FOR FLEET BAGENEMA LOT# 063031. LAB PHYSICAL ANALYSIS REPORT WERE REVIEWED. NO DEFICIENCIES RELATED TO THE NATURE OF CONSUMER'S REPORT WERE NOTED. THE COMPLAINT NARRATIVE REFERS TO THE BAGENEMA "TIP". THIS IS ACTUALLY THE TAPERED END OF THE TUBING ATTACHED TO THE ENEMA BAG. THE TUBING IS OF ONE PIECE MEASURING 60.5" PLUS OR MINUS 1.5%. EXAM OF THE DEVICE SHOWS IT IS EXTREMELY UNLIKELY THAT THE TAPERED TIP WOULD OR COULD SEPARATE WHEN DEVICE IS USED AS DIRECTED. THE TIP PROTECTOR IS A BLUE PVC CAP PLACED OVER THE TAPERED END OF THE ENEMA'S TUBING. THE PRODUCT CARTON INSTRUCTIONS STATE TO REMOVE THE BLUE PROTECTIVE SHIELD FROM THE ENEMA TIP PRIOR TO RECTAL INSERTION. INVESTIGATION CONCLUDES THE MOST PROBABLY CAUSE TO BE THAT THE CONSUMER FAILED TO REMOVE THE BLUE SHEATH PROTECTOR PRIOR TO RECTAL INSERTION. WHEN THE TUBING CLAMP WAS RELEASED THE FORCE CREATED BY FLUID FLOWING FROM THE ENEMA BAG THROUGH THE ATTACHED TUBING FORCED THE BLUE PROTECTIVE SHEATH INTO THE CONSUMER'S RECTUM. NO QUALITY ISSUES ARE NOTED.

Description of Event or Problem

A (B)(6) USED FLEET BAGENEMA ON (B)(6) 2008 FOR CONSTIPATION. THE PT REPORTED RECTAL BLEEDING AND ABDOMINAL PAIN FOLLOWING USE. THE PT REPORTED THAT ONCE THE CLAMP WAS RELEASED, THE TIP OF THE BAGENEMA "SHOT UP INTO HER INTESTINES." THE PT WENT TO THE EMERGENCY ROOM WHERE THE DOCTOR USED AN INSTRUMENT TO REMOVE THE TIP. THE PT DID NOT REQUIRE ADMISSION. EXPECTEDNESS: RECTAL HAEMORRHAGE: UNEXPECTED. ABDOMINAL PAIN: UNEXPECTED. ACCORDING TO THE PRODUCT LABEL. F/U ((B)(6) 2009): THE COMPANY RECEIVED THE PT'S MEDICAL RECORDS. THIS CASE IS NOW MEDICALLY CONFIRMED. PER THE EMERGENCY ROOM RECORDS, THE PT HAD FLEET'S TIP IN RECTUM WHICH WAS REMOVED BY THE PHYSICIAN'S FINGERS AND WITH HEMOSTATS. THE PT WAS TREATED AND RELEASED. EXPECTEDNESS: RECTAL HAEMORRHAGE: UNEXPECTED. ABDOMINAL PAIN: UNEXPECTED. FOREIGN BODY TRAUMA: UNEXPECTED. ACCORDING TO THE PRODUCT LABEL.